NCT05054400 is a EARLY_PHASE1 clinical trial of F18 Fluciclovine in Brain Metastases, sponsored by M.D. Anderson Cancer Center.

Who is sponsoring NCT05054400?

NCT05054400 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT05054400?

Interventions in NCT05054400: F18 Fluciclovine, Standard of Care.

What condition does NCT05054400 study?

NCT05054400 studies Brain Metastases, Cancer, Gliomas, Glioblastoma.

Is NCT05054400 still recruiting?

NCT05054400 is currently withdrawn. Last updated 1 September 2023.

Last reviewed 2023-09-01 · How we verify

NCT05054400

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR

Withdrawn EARLY_PHASE1 Last updated 1 September 2023

What this trial tests

EARLY_PHASE1 trial testing F18 Fluciclovine in Brain Metastases. Withdrawn.

Timeline

5 February 2020

Primary endpoint
29 August 2023

29 August 2023

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	EARLY_PHASE1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	5 February 2020
Primary completion	29 August 2023
Estimated completion	29 August 2023
Sites	1 location across United States

Drugs / interventions tested

F18 Fluciclovine — full drug profile →
Standard of Care

Conditions studied

Brain Metastases — all drugs for Brain Metastases →
Cancer — all drugs for Cancer →
Gliomas — all drugs for Gliomas →
Glioblastoma — all drugs for Glioblastoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Brain Metastases or Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to assess the relationship between brain malignancy volume as defined by post-contrast T1 weighted and F18 Fluciclovine before and following LITT. We hypothesize that imaging with F18 Fluciclovine will be superior to anatomic MR imaging in lesion volume assessment before treatment and that residual F18 Fluciclovine defined tumor will predict local post-LITT disease recurrence.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Programmed cell death disrupts inflammatory tumor microenvironment (TME) and promotes glioblastoma evolution.
Liang T, Gu L, Kang X, Li J, et al · · 2024 · cited 13× · PMID 38890642 · DOI 10.1186/s12964-024-01602-0
Therapeutic manipulation and bypass of the blood-brain barrier: powerful tools in glioma treatment.
Giantini-Larsen AM, Pandey A, Garton ALA, Rampichini M, et al · · 2025 · cited 8× · PMID 39877748 · DOI 10.1093/noajnl/vdae201

Verify or expand the search:

Other recruiting trials for Brain Metastases

Currently open trials in the same condition.

NCT07464470 — Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers · recruiting
NCT07481786 — Bevacizumab Plus FSRT Versus Hippocampus-Avoidant WBRT in Lung Adenocarcinoma With Extensive Brain Metastases · Phase 3 · recruiting
NCT07227610 — Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT) · Phase 2 · recruiting
NCT07448493 — Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer · active not recruiting
NCT07053033 — Laser Interstitial Thermal Therapy (LITT) or Surgery and Adjuvant Reirradiation for Recurrent Brain Metastases (LaSAR Be · Phase 2 · recruiting

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05054400 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 1 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05054400.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing